Injection yeNivolumab

-Delile

• Ngaphambi kokuthola umjovo we-nivolumab,

Kusetshenziswa umjovo weNivolumab:

• iyodwa noma ihlanganiswe ne-ipilimumab (Yervoy) yokwelapha izinhlobo ezithile ze-melanoma (uhlobo lomdlavuza wesikhumba) oluye lwasakazeka kwezinye izingxenye zomzimba noma olungasuswa ngokuhlinzwa,
• ukwelapha nokuvimbela ukubuya kohlobo oluthile lwe-melanoma ngemuva kokuhlinzwa ukuyisusa kanye nanoma yiziphi izicubu ezithintekile nama-lymph node,
• kuhlanganiswe ne-ipilimumab (Yervoy) ukwelapha uhlobo oluthile lomdlavuza wamaphaphu (non-small cell lung cancer cancer; NSCLC) eye yasakazekela kwezinye izitho zomzimba,
• ngokuhlangana ne-ipilimumab (Yervoy) kanye ne-platinum chemotherapy yokwelapha uhlobo oluthile lwe-NSCLC olubuyile noma olusabalale kwezinye izingxenye zomzimba,
• kukodwa ukwelapha uhlobo oluthile lwe-NSCLC olusabalale lwaya kwezinye izingxenye zomzimba futhi luye lwashuba phakathi noma ngemuva kokwelashwa ngemithi ye-platinum chemotherapy,
• ukwelapha olunye uhlobo lomdlavuza wamaphaphu (umdlavuza omncane wamaphaphu wamangqamuzana, i-SCLC) osabalalele kwezinye izingxenye zomzimba owaqhubeka usiba nzima ngemuva kokwelashwa ngemuva kweplatinum chemotherapy futhi okungenani neminye imishanguzo yamakhemikhali,
• ukwelapha i-renal cell carcinoma (RCC, uhlobo lomdlavuza oluqala kumaseli ezinso) oluye lwakhula ngemuva kokwelashwa ngeminye imithi ye-chemotherapy,
• ngokuhlangana ne-ipilimumab (Yervoy) ukwelapha i-RCC esezingeni eliphakeme kubantu abangazange belashwe ngeminye imithi ye-chemotherapy,
• ukwelapha i-Hodgkin's lymphoma (isifo sikaHodgkin) kubantu abadala abagula kakhulu noma abangaphendulanga ekufakweni kwe-autologous stem cell (inqubo lapho kususwa khona amangqamuzana athile egazi emzimbeni bese ibuyiselwa emzimbeni ngemuva kokwelashwa ngamakhemikhali kanye / noma ukwelashwa ngemisebe) kanye ne-brentuximab vedotin (Adcetris) ukwelashwa noma ezinye izindlela zokwelashwa ezintathu kubandakanya ukufakelwa kwe-stem cell,
• ukwelapha uhlobo oluthile lomdlavuza wekhanda nentamo oqhubeka ubuya noma osabalele kwezinye izingxenye zomzimba noma waba muncu ngesikhathi noma ngemuva kokwelashwa ngeminye imithi ye-chemotherapy,
• ukwelapha umdlavuza we-urothelial (umdlavuza wendwangu yesinye nezinye izingxenye zomgudu wokuchama) osakaze kwezinye izingxenye zomzimba futhi uye waba mubi phakathi noma ngemuva kokwelashwa ngeminye imishanguzo ye-chemotherapy,
• iyodwa noma ihlanganiswe ne-ipilimumab yokwelapha uhlobo oluthile lomdlavuza obomvu (umdlavuza oqala emathunjini amakhulu) kubantu abadala nasezinganeni ezineminyaka engu-12 ubudala nangaphezulu osusakazekele kwezinye izitho zomzimba futhi uye waba mubi ngemuva kokwelashwa ngamanye amakhemikhali imithi,
• iyodwa noma ihlanganiswe ne-ipilimumab yokwelapha i-hepatocellular carcinoma (HCC; uhlobo lomdlavuza wesibindi) kubantu abake baphathwa nge-sorafenib (Nexafar),
• ukwelapha umdlavuza wamangqamuzana we-esophageal squamous cell (umdlavuza webhubhu oxhuma umphimbo wakho nesisu sakho) osusabalele kwezinye izingxenye zomzimba, uye waba mubi ngemuva kokwelashwa ngeminye imithi ye-chemotherapy, noma ongeke welashwe ngokuhlinzwa,
• futhi ngokuhambisana ne-ipilimumab yokwelapha i-mesothelioma ebulalayo (uhlobo lomdlavuza oluthinta ulwelwesi lwangaphakathi lwamaphaphu nomgodi wesifuba) kubantu abadala abangenakususwa ngokuhlinzwa.

UNivolumab usesigabeni semithi ebizwa ngama-antibody monoclonal. Isebenza ngokusiza amasosha akho omzimba ukwehlisa noma ukumisa ukukhula kwamangqamuzana omdlavuza.

INivolumab iza njengoketshezi oluzofakwa emthanjeni ngaphezu kwemizuzu engama-30 ngudokotela noma umhlengikazi esibhedlela noma esikhungweni sezokwelapha. Lapho i-nivolumab inikezwa yodwa ukwelapha i-melanoma, umdlavuza ongewona omncane wamaphaphu (NSCLC), i-Hodgkin lymphoma, umdlavuza wekhanda nowentamo, umdlavuza we-urothelial, i-RCC esezingeni eliphezulu, umdlavuza obala, umdlavuza weseli we-esophageal squamous cell, noma i-hepatocellular carcinoma, uvame ukunikezwa kanye njalo emavikini ama-2 noma ama-4 ngokuya ngomthamo wakho inqobo nje uma udokotela wakho encoma ukuthi uthole ukwelashwa. Lapho i-nivolumab inikezwa yodwa ukwelapha umdlavuza omncane wamaphaphu wamangqamuzana (i-SCLC), imvamisa inikezwa kanye emavikini amabili uma nje udokotela wakho encoma ukuthi uthole ukwelashwa. Lapho i-nivolumab inikezwa ihlanganiswe ne-ipilimumab yokwelapha i-melanoma, i-hepatocellular carcinoma, umdlavuza obala ngokobuhlanga, noma i-RCC, ivame ukunikezwa kanye njalo emavikini ama-3 ngemithamo emi-4 ene-ipilimumab, bese iba yodwa kanye njalo emavikini ama-2 noma ama-4 kuye ngomthamo wakho we-as inqobo nje uma udokotela wakho encoma ukuthi uthole ukwelashwa. Lapho i-nivolumab inikezwa ihlanganiswe ne-ipilimumab ukwelapha i-NSCLC, imvamisa inikezwa kanye njalo emavikini ama-2 inqobo nje uma udokotela wakho encoma ukuthi uthole ukwelashwa. Lapho i-nivolumab inikezwa ihlangene ne-ipilimumab yokwelapha i-mesothelioma ebulalayo, ivame ukunikezwa kanye emavikini amathathu uma nje udokotela wakho encoma ukuthi uthole ukwelashwa. Lapho i-nivolumab inikezwa ihlanganiswe ne-ipilimumab ne-platinum chemotherapy yokwelapha i-NSCLC, imvamisa inikezwa kanye emavikini ama-3 inqobo nje uma udokotela wakho encoma ukuthi uthole ukwelashwa.

I-Nivolumab ingadala ukusabela okungathi sína noma okusongela ukuphila ngesikhathi sokufakwa. Udokotela noma umhlengikazi uzokubuka eduze ngenkathi uthola ukumnika futhi ngemuva nje kokufakwa ukuze aqiniseke ukuthi awunampendulo emikhulu emithini. Tshela udokotela wakho noma umhlengikazi ngokushesha uma uhlangabezana nalezi zimpawu ezilandelayo ezingavela ngesikhathi sokufakwa: ukugodola noma ukuqhaqhazela, ukulunywa, ukuqubuka, ukuqhuma, ukuphefumula kanzima, isiyezi, umkhuhlane nokuzizwa uphela amandla.

Udokotela wakho anganciphisa ukumnika kwakho, akubambezele, noma ayeke ukwelashwa kwakho ngomjovo we-nivolumab, noma akuphathe ngemithi eyengeziwe ngokuya ngempendulo yakho emithini kanye neminye imiphumela emibi ohlangabezana nayo. Khuluma nodokotela wakho mayelana nokuthi uzizwa kanjani ngesikhathi sokwelashwa kwakho.

Udokotela wakho noma usokhemisi uzokunikeza ishidi lemininingwane yesiguli lomkhiqizi (Umhlahlandlela Wezokwelapha) lapho uqala ukwelashwa ngomjovo we-nivolumab. Funda imininingwane ngokucophelela bese ubuza udokotela noma usokhemisi wakho uma unemibuzo.

Lo muthi ungabekelwa okunye ukusetshenziswa; buza udokotela wakho noma usokhemisi ukuthola eminye imininingwane.

Ngaphambi kokuthola umjovo we-nivolumab,

• Tshela udokotela wakho kanye nosokhemisi uma unegciwane ku-nivolumab, noma imiphi eminye imithi, noma yiziphi izithako zomjovo we-nivolumab. Buza usokhemisi wakho noma uhlole Umhlahlandlela Wezokwelapha ukuthola uhlu lwezithako.
• Tshela udokotela wakho kanye nosokhemisi ukuthi imiphi eminye imishanguzo kadokotela neyokungabhalisi, amavithamini, izithasiselo zokudla okunempilo, nemikhiqizo yamakhambi oyithathayo noma ohlela ukuyithatha. Udokotela wakho angadinga ukushintsha imithamo yemithi yakho noma akuqaphele ngokucophelela ngemiphumela emibi.
• Tshela udokotela wakho uma ngabe uke wafakelwa isitho somzimba. Tshela nodokotela wakho uma uke waba nesifo sokuzilimaza (isimo lapho amasosha omzimba ahlasela khona ingxenye enempilo yomzimba) njengesifo sikaCrohn (isimo lapho amasosha omzimba ehlasela ulwelwesi lwendlela yokugaya edala ubuhlungu, isifo sohudo, ukwehla kwesisindo, nomkhuhlane), i-ulcerative colitis (isimo esidala ukuvuvukala nezilonda kulwelwesi lwekholoni [amathumbu amakhulu] ne-rectum), noma i-lupus (isimo lapho amasosha omzimba ahlasela khona izicubu nezitho eziningi kubandakanya isikhumba, amalunga, igazi, nezinso); noma yiluphi uhlobo lwesifo samaphaphu noma izinkinga zokuphefumula; noma isifo segilo, sezinso noma sesibindi.
• utshele udokotela wakho uma ukhulelwe noma uhlela ukukhulelwa. Uzodinga ukuthatha isivivinyo sokukhulelwa ngaphambi kokuthola i-nivolumab. Akufanele ukhulelwe ngenkathi uthola umjovo we-nivolumab. Kufanele usebenzise ukulawulwa kokubeletha okusebenzayo ukuvimbela ukukhulelwa ngesikhathi sokwelashwa kwakho ngomjovo we-nivolumab futhi okungenani izinyanga eziyi-5 ngemuva komthamo wakho wokugcina. Khuluma nodokotela wakho ngezindlela zokulawula ukubeletha ezizokusebenzela. Uma ukhulelwa ngenkathi uthola umjovo we-nivolumab, shayela udokotela wakho ngokushesha. Umjovo weNivolumab ungalimaza umbungu.
• tshela udokotela wakho uma uncelisa noma uhlela ukuncelisa. Akufanele uncelise ngenkathi uthola umjovo we-nivolumab nezinyanga ezi-5 ngemuva komthamo wakho wokugcina.

Ngaphandle kokuthi udokotela wakho akutshele ngenye indlela, qhubeka nokudla okuvamile.

Uma uphuthelwa isikhathi sokuthola umjovo we-nivolumab, shayela udokotela wakho ngokushesha okukhulu.

Umjovo weNivolumab ungadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:

• ubuhlungu obuhlangene, emuva, emhlathini, noma bethambo
• ubuhlungu bemisipha noma ubuthakathaka
• isikhumba esomile, esiqhekekile, esinenkani
• ububomvu, ukuvuvukala, noma ubuhlungu ezintendeni zezandla zakho noma ematheni ezinyawo zakho
• izilonda zomlomo
• amehlo omile noma umlomo

Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nenye yalezi zimpawu noma lezo ezisohlwini lwe-HOW section, tshela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:

• ukuphelelwa umoya
• ukukhwehlela okusha noma okuba kubi kakhulu
• ekhwehlela igazi
• ubuhlungu besifuba
• isifo sohudo
• ubuhlungu bendawo yesisu noma isisa
• indle emnyama, elindile, enamathelayo, noma equkethe igazi
• ukukhathala noma ubuthakathaka
• ngizwe kubanda
• ukujula kwezwi noma ukushaqeka
• izinguquko esisindweni (ukuzuza noma ukulahleka)
• ushintsho esimweni sokuziphatha noma ekuziphatheni (kwehle ukushayela ucansi, ukucasuka, noma ukukhohlwa)
• ukuqina kwentamo
• ubuhlungu, ukushisa, ukugedlezela, noma ukuba ndikindiki ezandleni noma ezinyaweni
• ukuphathwa ikhanda, kufaka phakathi lezo ezingajwayelekile noma ezingeke zisuswe
• ukusangana (ukubona izinto noma ukuzwa amazwi angekho)
• isithuthwane
• ukudideka
• imfiva
• ukulahleka kwezinwele
• ukulunywa, ukuqubuka, isifuba noma amabhamuza esikhunjeni sakho
• ukuqunjelwa
• isicanucanu
• ukuhlanza
• ukozela
• isiyezi noma ukuquleka
• ukuphuzi kwesikhumba noma kwamehlo, umchamo onombala omnyama, ukopha noma ukulimaza kalula kunokujwayelekile, ukulahlekelwa isifiso sokudla, amandla anciphile, noma ubuhlungu ohlangothini lwesokunene sendawo yesisu
• ukoma okwandisiwe
• ukuncipha noma ukwanda kokuchama
• ukuvuvukala kobuso, izingalo, imilenze, izinyawo noma amaqakala
• igazi emchameni
• izinguquko embonweni
• umoya onuka izithelo

Umjovo weNivolumab ungadala eminye imiphumela emibi. Shayela udokotela wakho uma unezinkinga ezingavamile ngenkathi uthola lo muthi.

Uma uthola imiphumela emibi kakhulu, wena noma udokotela wakho ungathumela umbiko kuhlelo lwe-Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting online (http://www.fda.gov/Safety/MedWatch) noma ngocingo ( 1-800-332-1088).

Gcina wonke ama-aphoyintimenti nodokotela wakho kanye nelabhorethri. Udokotela wakho uzo-oda izivivinyo ezithile zelebhu ukuze ahlole impendulo yomzimba wakho kumjovo we-nivolumab. Kwezinye izimo, udokotela wakho uzokuyalela ukuhlolwa kwelebhu ngaphambi kokuba uqale ukwelashwa kwakho ukuze ubone ukuthi umdlavuza wakho ungelashwa nge-nivolumab.

Kubalulekile ukuthi ugcine uhlu olubhaliwe lwayo yonke imishanguzo oyisebenzisayo kadokotela kanye nokungabhaliswanga (ngaphezulu kokuthenga), kanye nanoma yimiphi imikhiqizo efana namavithamini, amaminerali, noma ezinye izithako zokudla. Kufanele uze nalolu hlu njalo uma uvakashela udokotela noma uma ungeniswa esibhedlela. Kubaluleke kakhulu futhi nemininingwane ebalulekile ukuthi uphathe uma kwenzeka kunezimo eziphuthumayo.

• I-Opdivo^®